Deflecting guide catheter for use in a minimally invasive medical procedure for the treatment of mitral valve regurgitation

ABSTRACT

A deflecting guide catheter for use in minimally invasive medical procedures such as the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The catheter includes an elongated tubular portion having various durometers along its length and at least one puller wire attached to an anchor band near the distal end. The deflecting guide catheter is used to provide a means for guiding a plication device or other medical instrument into a desired position within the vasculature or heart chambers of a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/249,388 filed on Oct. 10, 2008 which claims the benefit ofU.S. Provisional Patent Application No. 60/981,303 filed Oct. 19, 2007which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a device and method for treating thevasculature and internal organs of a patient. Particularly, the presentinvention is directed to a deflecting guide catheter for use in a systemand method for treating mitral valve regurgitation in the heart of apatient using direct plication annuloplasty.

BACKGROUND OF THE INVENTION

Catheter based devices are used to treat a wide variety of medicalproblems in a minimally invasive manner. Catheters are used to place andexpand angioplasty balloons used to widen veins and arteries narrowed byplaque. Small scaffolds called stents have been introduced into thevasculature using catheter-based systems in order to prevent therestenosis of such vessels. One of the problems that a catheter baseddevice and system could be used to treat in a minimally invasive manneris mitral valve regurgitation, however, no commercially successfuldevice for the treatment of mitral valve regurgitation in such a mannercurrently exists.

Mitral valve regurgitation is the backflow of blood from the leftventricle into the left atrium due to an improper alignment of theleaflets of the mitral valve thereby causing an imperfect closure of thevalve. A gap between the anterior leaflet and posterior leaflet of themitral valve is created by the improper closure providing a conduit forblood to flow through the mitral valve in a retrograde manner from theleft ventricle to the left atrium. This gap may be a congenital defector may be caused by disease, i.e., ischemic or idiopathic cardiomyopathyand/or intrinsic degenerative disease of components of the mitral valveapparatus. One type of condition, congestive heart failure (CHF), causesthe heart to enlarge. In an enlarged heart the walls of the leftventricle are expanded or dilated which causes the papillary muscles tobe displaced downward and/or outward resulting in a tethering of thechordae tendineae and subsequent tethering/pulling on the leaflets.Also, with CHF, the mitral annulus is dilated. The combination of thedilated annulus and the tethering on the leaflets prevents the leafletsfrom closing properly, thereby causing the problematic gap in the mitralvalve. The resultant backflow through the mitral valve reduces theefficiency of the heart resulting in a need for the heart to beat fasterand/or more forcefully in order to produce the same amount of bloodflow. Mitral valve regurgitation may be asymptomatic in some patientsbut in other patients the reduction in blood flow and the resultantstrain on the heart could result in arrhythmias, heart attack andpossibly death.

The preferred current treatments for mitral valve regurgitation requireopen-heart surgery and/or the use of endoscopic techniques that aredifficult for the surgeon and potentially dangerous for the patient. Inone method of treatment, porcine heart valves or mechanical heart valvesare used to replace the damaged or defective mitral valve. Suchtreatments require the use of open-heart surgery to accomplish theimplantation. Such heterologous valves may be used in humans but oftenwear-out prematurely and additional open-heart surgery is required toreplace such valves with additional heterologous or mechanical valves.Mechanical valves have been developed which may also be used as areplacement for a defective mitral valve, however, the implantation of amechanical valve usually indicates long-term anti-coagulant therapy toprevent clots from developing around the valve that could lead to adangerous embolism. Long-term anticoagulant treatment causes otherproblems such as unwanted internal and external bleeding and possiblystrokes.

Another open-heart surgical procedure for treating functional mitralvalve regurgitation is annuloplasty. In an annuloplasty procedure, agenerally “D” shaped annuloplasty ring is implanted on the mitral valveannulus to reduce the size of the stretched mitral valve annulus, mostimportantly, the septal-lateral dimension and improve closing (orcoaptation) of the valve thereby reducing regurgitation. The surgeonsurgically attaches, i.e., sews, the annuloplasty ring to the mitralvalve on the atrial side of the mitral valve. The annuloplasty ring issewn to the annulus on a top portion (i.e., the atrial side) of themitral valve. Once implanted, tissue generally grows over theannuloplasty ring, and a line of contact between the annuloplasty ringand the mitral valve will essentially enable the mitral valve to appearand function as a normal mitral valve by reestablishing coaptation ofthe mitral valve leaflets but the durability of the effect is variableand may decline within six months after the procedure. Although apatient who receives the annuloplasty ring may be subjected toanti-coagulant therapies, the therapies are not extensive, as a patientis only subjected to the therapies for a matter of weeks, e.g., untiltissue grows over the annuloplasty ring.

A second open-heart surgical procedure used in the treatment ofdegenerative mitral valve regurgitation is the Alfieri stitch procedurewhich the uses an edge-to-edge suture in the mitral valve. Anedge-to-edge stitch is used to stitch together an area at approximatelythe center of a gap defined between the anterior and posterior leafletsof the mitral valve. Once the stitch is in place, the stitch is pulledin to form a suture that holds the anterior leaflet against theposterior leaflet. By reducing the size of the gap between the anteriorleaflet and the posterior leaflet, the amount of leakage through themitral valve may be substantially reduced. Durability has been a concernfor Alfieri procedures done without the addition of an annuloplastyring. In addition, use of the edge-to-edge procedure is only indicatedin certain degenerative pathologies where the primary abnormality or gapbetween the leaflets is centrally located.

Another method of treating mitral valve regurgitation is theimplantation of a ventricular assist device. Such devices are expensiveand difficult to implant and require the patient to use anti-coagulanttherapy indefinitely. Long-term use of anti-coagulant therapy may resultin unnecessary bleeding and strokes. Such ventricular assist devicesare, therefore, indicated for use only in patients that would likely notsurvive without their use and are used to keep patients alive who arecandidates for heart transplant surgery. Left ventricular assist devicesare a “bridge” therapy rather than a final therapy.

While such invasive surgical procedures have under certain circumstancesbeen shown to be effective in the treatment of mitral valve leakage,invasive surgical procedures often have significant drawbacks. Any timea patient undergoes open-heart surgery, there is a risk of infection.Opening the sternum and using a cardiopulmonary bypass machine has alsobeen shown to result in a significant incidence of both short and longterm neurological deficits.

Some minimally invasive procedures have been developed to treat mitralvalve regurgitation but, to date, none have become commerciallysuccessful standard procedures. U.S. Pat. No. 6,619,291 to Hvlaka et al.discloses a minimally invasive method of performing annuloplastyincluding inserting an implant into a left ventricle and orienting theimplant in the left ventricle substantially below the mitral valve. Theimplant and tissue around the mitral valve are connected and tension isprovided to the implant in order to substantially reduce an arc lengthassociated with the mitral valve.

In U.S. Pat. Nos. 6,718,985 and 7,037,334 to Hvalaka et al. a series ofplications near the mitral valve are created by T-bars that are threadedtogether to reshape the mitral valve. In U.S. Pat. No. 7,166,127 acatheter based system for treatment of mitral valve regurgitation uses aretainers adapted to be secured to the annulus of the mitral valve withflexible tensile members coupled to the retainers. A crimping devicedeployable through the catheter compresses a crimp onto the flexibletensile members after they are pulled toward one another to reduce thecircumferential length of the annulus. In this system the number ofpermanent implants required in order to achieve an initial effect, andcommitment to these implants before success of effect is able to bedetermined are serious drawbacks.

In United States Patent Application Publication No. 2007/0093857, Rogerset al. describes a device and method for the treatment of mitral valveregurgitation using a minimally invasive procedure in which plicationsare made proximate the mitral valve of the patient and a retainer isplaced to hold the plication.

United States Patent Application No. 2007/0032797 discloses a device forreducing the size of the stomach having a corkscrew-shaped anchor forplacement in the gastric wall.

United States Patent. Application No. 2007/0025737 to Messerly et al.discloses a surgical retainer having a generally helical shape and adevice having jaws for grasping tissue into which the helical retainermay be driven.

United States Patent Application No. 2007/0055335 discloses an electrodeprobe having a corkscrew-shaped distal tip for use in cardiologyapplications.

The need remains for a device and method for treating mitral valveregurgitation that can be used efficiently and effectively in aminimally invasive procedure and that provides the physician with theability to know that the procedure has resulted in the desired effectprior to removing the device from the patient thereby reducing the needfor and expense of repeat procedures. Such a procedure should providethe physician with the ability to changes the effect on the mitral valveduring the procedure before taking an irreversible action.

SUMMARY OF THE INVENTION

The present invention provides a system and method for the treatment ofmitral valve regurgitation. The method preferably uses a femoralretrograde approach of crossing the aortic valve. Access to the leftventricle is achieved through the aortic valve using the standardretrograde femoral artery approach utilizing a rounded crossing catheter(CC) preferably with a “J” or pigtail configuration. A deflecting guidecatheter is then sent over the crossing catheter into the leftventricle. When the distal end of the deflectable catheter is in theleft ventricle the crossing catheter is removed. The deflectable guideis preferably, but need not be, positioned between the papillary muscleswith the distal segment lying along the posterior wall of the leftventricle and its tip is pointing towards the underside of the posteriormitral valve annulus. A plication device is then introduced through thedeflectable catheter and is advanced out of the distal end of thedeflectable catheter and is directed at the underside of the mitralvalve, more preferably into the subvalvular groove and positioned so asto be able to grasp and plicate the tissue of the mitral valve at ornear the annulus.

A test plication of the mitral valve annulus is created and theappropriateness of the plication is examined using imaging means such asTEE, ICE, TTE or fluoroscopy with or without contrast injection. If theplication is determined to be appropriate then a retainer is applied tothe plication to retain the tissue in the plicated state. If theplication is not satisfactory then a retainer is not applied and thejaws of the plication device are released and the plicator isrepositioned to plicate a different tissue target at or near the annulusof the mitral valve. Such “test” plications may be repeated a number oftimes prior to deploying the retainer.

If a single plication and retainer do not sufficiently reshape themitral valve to correct the regurgitation then the original deflectableguide is repositioned and a second plicator with a retainer isintroduced into the delivery guide and positioned and used in the samemanner. Alternatively, a multi-retainer plicator can be used to providethe second or third retainers as necessary during the procedure withoutrequiring the removal and reintroduction of the plication device. Oncesatisfactory changes in the annular geometry of the mitral valve andconcomitant reduction in mitral valve regurgitation is achieved then theplication device and the deflectable guide are fully withdrawn and thefemoral access site is closed using conventional closing techniques.

Four components comprise the total system for percutaneous directplication annuloplasty. The first is a prolapsable or curved tipcrossing catheter preferably having a “J” or pigtail configuration. Thismay be used with or without a guidewire. In either case the crossingcatheter is inserted in a stack or telescoped configuration with thesecond component, a deflecting guide catheter within which the crossingcatheter is initially telescoped or stacked. The deflecting guidecatheter is used to provide a means for guiding the plication deviceinto proper position on the underside of the mitral valve preferably atthe subvalvular region of the mitral valve at or near the annulus. Thethird component of the system is a plication device that has an endeffector having opposing members at least one of which can bemanipulated to open. The plication device is used to grasp tissue andalso contains at least one retainer to retain the tissue in the plicatedform if desired. The retainer in the preferred embodiment is a “C”shaped retainer having an end portion and two substantiallyperpendicular prongs that are pushed into the plicated tissue. The endsof the prongs may be compressed to increase the pressure on the plicatedtissue and to prevent the retainer from being dislodged from theplicated tissue.

The present invention provides a deflecting guide catheter for guiding amedical device through a lumen of a patient during a medical proceduresuch as mitral valve annuloplasty comprising an elongated tubular bodyportion having a lumen and a distal end and proximal end, an anchor bandnear the distal end of the elongated tubular body portion, a handleassembly attached to the proximal end of the elongated tubular bodyportion wherein the handle assembly comprises an actuator assembly andat least one puller wire connected from the actuator assembly to theanchor band wherein movement of the actutator assembly in a proximaldirection causes proximal movement of the puller wire and deflection ofthe distal end of the deflecting guide catheter. At least one prong onthe actuator assembly engages at least one tooth in a rack mounted inthe handle assembly in order to retain the position of the puller wirein the proximal direction.

The actuator assembly further comprises at least one pivot point axelpin and a spring that biases the prong of the actuator assembly againstthe rack. A release trigger provides a means for removing the springbias and permitting distal movement of the actuator assembly therebyreducing the deflection of the distal end of the deflecting guidecatheter. The anchor band to which the puller wire is attached isembedded in the wall of the elongated tubular portion. The handleassembly further comprises a hemostasis valve at the proximal end forpassage of the medical device through the handle assembly and into thelumen of the elongated tubular portion. The puller wire is comprised ofhigh tensile strength material, preferably having a tensile strengthgreater than 300 ksi. The puller wire may be stainless steel or ahigh-strength woven fiber such as Kevlar or Vectran. The puller wire mayalso be comprised of MP35N or other high strength metallic alloys.

In the deflecting guide catheter of the present invention the elongatetubular body portion comprises a distal region, an intermediate distalregion, a main intermediate region and a proximal region. In oneembodiment these regions are of increasing stiffness from the distal endto the proximal end. The distal region is approximately a fewcentimeters in length and is made of a polymeric material blended with aradiopaque material such as bismuth subcarbonate. A first anchor band isembedded near the distal end of the distal region and a second anchorband is embedded near the proximal end of distal region. The durometerof the polymeric material of the distal region is between approximately25 D and 40 D, preferably 35 D and further comprises an extrudedatraumatic tip at its distal end having a slight taper toward its distalend which may also be a polymeric material blended with a radiopaquematerial. The intermediate distal region is comprised of a polymericmaterial having a higher durometer than the distal region. The polymericmaterial of the intermediate distal region preferably has a durometerbetween approximately 35 D and 55 D. The main intermediate region iscomprised of a polymeric material having a higher durometer than theintermediate distal region, preferably between approximately 55 D and 63D. The proximal region is comprised of a polymeric material having adurometer of approximately 72 D. In an alternative embodiment thestiffness of the material comprising the distal region is greater thanthe stiffness of the intermediate distal region.

The elongate tubular body portion of the deflecting guide catheter ofthe present invention is comprised of a lubricious liner, a tubular wirebraid and a polymeric material. The anchor bands are embedded in thepolymeric material between the lubricious liner and tubular wire braid.The deflecting guide catheter may further comprise a second puller wireattached to a second anchor band near the intermediate distal end of thedeflecting guide catheter for deflecting the intermediate distal end anddistal end of the deflecting guide catheter in response to proximalmovement of the second puller wire caused by proximal movement of asecond actuator assembly attached to the proximal end of the secondpuller wire. At least one prong on the second actuator assembly engagesat least one tooth located in the handle assembly in order to retainmovement of the second puller wire in the proximal direction. The secondactuator assembly further comprises at least one pivot point axel pinand a spring that biases the prong of the actuator assembly against therack. The second actuator assembly further comprises a release triggerfor removing the spring bias and permitting distal movement of theactuator assembly thereby reducing the deflection of the distal end ofthe deflecting guide catheter and further comprises a lumen throughwhich the first puller wire passes. Proximal movement of the secondpuller wire causes the deflecting guide catheter to deflect in adifferent plane from the deflection caused by proximal movement of thefirst puller wire. The second puller wire may be attached to the secondanchor band at a position that is spaced radially apart from theposition at which the first puller wire attaches to the first anchorband. Alternatively, the second puller wire attaches to a position onthe second anchor band that is minimally spaced apart radially from thepoint of attachment of the first puller wire to the first anchor bandthereby causing the distal tip of the catheter to deflect insubstantially the same plane when the first and second puller wires aremoved in the proximal direction. The first anchor band may have a notchor lumen therein for passage of the second anchor wire therethrough.

The first actuating assembly of the deflecting guide catheter of thepresent invention comprises a first hyptotube attached to its distal endand the second actuating assembly comprises a second hypotube attachedto the proximal end which is adapted to be telescopically receivedwithin the first hyptotube said first and second hypotubes are adaptedto receive the first puller wire. At least one magnetic location sensormay be mounted near the distal end for determining the location of thedistal end of the deflecting guide catheter in conjunction with amagnetic location sensing system. The elongated tubular body portion maybe comprised of polymeric materials having two different durometers usedin a radially alternating pattern with a first material used in twocircumferential portions opposite one another and a second material usedin two other opposing circumferential portions where the durometer ofthe first material is greater than the durometer of the second material.In one embodiment the first puller wire is attached to the first anchorband at a position in the first material and the second puller wire isattached to a second anchor band at a position in the second material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are a flow diagram describing the method of treatingmitral valve regurgitation in accordance with the present invention.

FIGS. 2A-H depict the stages of the various steps of the method oftreating mitral valve regurgitation in accordance with the presentinvention.

FIG. 3 depicts the plication regions in the method of treating mitralvalve regurgitation in accordance with the present invention.

FIG. 4 is a perspective view of a crossing catheter for use in treatingmitral valve regurgitation in accordance with the present invention.

FIG. 5 is a cutaway view of a portion of the body of the crossingcatheter of FIG. 4.

FIG. 6 is an elevational view of a deflecting guide catheter for use intreating mitral valve regurgitation in accordance with the presentinvention.

FIGS. 7A and 7B are an exploded view and a perspective view respectivelyof the components of a handle for the deflecting guide catheter of FIG.6.

FIG. 8 is an elevational view of the body portion of the deflectingguide catheter of FIG. 6.

FIGS. 9A and 9B are cross-sectional views of the body portion of thedeflecting guide catheter of FIG. 8 taken through lines A and Brespectively. FIG. 9C is a cross-sectional view of an alternativeembodiment of the arrangement of the anchor bands in the distal tip ofthe deflecting guide catheter.

FIGS. 10A-10C are perspective views of the body portion of otherembodiments of a deflecting guide catheter for use in treating mitralvalve regurgitation

FIG. 11 is an exploded perspective view of another embodiment of thehandle and internal components used in a deflecting guide catheter inaccordance with the present invention.

FIG. 12 is an elevational view of a plication device for use in treatingmitral valve regurgitation in accordance with the present invention.

FIG. 13 is an elevational view of the plication device of FIG. 12 with aportion removed to expose the internal components.

FIG. 14A is an elevational view of the plication device of FIGS. 12 and13 from the shuttle assembly to the distal end.

FIG. 14B is a cross sectional view of the portion of the plicationdevice of FIG. 14A taken through line A-A.

FIG. 14C is an enlarged view of proximal end section D of thecross-sectional view of the portion of the plication device of FIG. 14B.

FIG. 14D is an enlarged view of distal section C of the cross-sectionalview of the portion of the plication device of FIG. 14B.

FIG. 14E is an enlarged view of the distal tip section B of thecross-sectional view of the portion of the plication device of FIG. 14B.

FIG. 14F is an enlarged planar view of the distal tip of the plicationdevice of FIG. 14A.

FIG. 14G is a detailed perspective view depicting the coupling of theend-effector control wire to the distal puller wires.

FIG. 14H is a detailed perspective view depicting the coupling of theend-effector control wire to the distal puller wires in an embodiment ofthe plication device having passive articulation.

FIG. 15 is a perspective view of a retainer for use in a plicationdevice for use in the treatment of mitral valve regurgitation inaccordance with the present invention.

FIGS. 16A-16D are elevational views of the distal end of variousembodiments of a plication device in accordance with the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a flow diagram depicting a method of providing directplication annuloplasty to the mitral valve in a heart such as thatdepicted in FIG. 2A in accordance with the present invention. At step100 the procedure begins with a puncture for access to the femoralartery using standard techniques. At step 102 the physician or otherpractitioner places a catheter sheath introducer (CSI) into the femoralaccess point using standard techniques. Any known CSI may be used in theprocedure with the preferable size being approximately 14 french. Atstep 104 a crossing catheter, preferably prolapseable or having a curvedtip, and a deflecting guide catheter are inserted together in a “stack”formation through the CSI. Alternatively, the deflecting guide catheteris inserted through the CSI without a crossing catheter although the useof a crossing catheter is the preferred method. The crossing catheter isdescribed herein in greater detail with respect to FIGS. 4 and 5 belowand the deflecting guide catheter is described herein in greater detailwith respect to FIGS. 6 to 11. The stacked crossing catheter anddeflecting guide catheter are advanced through the arterial system ofthe patient traversing the aorta of the patient in a retrograde mannerat step 106. At step 108 the aortic valve (AV) is crossed with thecrossing catheter and the crossing catheter is advanced into the leftventricle (LV) as depicted in FIG. 2B. At step 110 the deflecting guidecatheter is advanced over the crossing catheter through the aortic valveand into the left ventricle as depicted in FIG. 2C. The deflecting guidecatheter is deflected in a somewhat retroflexed manner as it is advancedapproximately toward the mitral valve at step 112 as depicted in FIG. 2Dand the crossing catheter is withdrawn at step 114.

A guidewire may also be used with the crossing catheter and deflectingguide catheter in a three-element stack inserted in the CSI. If aguidewire is used it is advanced first through the arterial system andover the aortic arch followed by the combined stack of the crossingcatheter and the deflecting guide catheter. The guidewire is introducedfirst through the aortic valve followed by the crossing catheter whichis preferably oriented into a position between the papillary musclesalthough this is not necessary. The procedure then continues as in steps110 and 112 above with the guidewire removed simultaneously with thecrossing catheter at step 114.

Whether or not a guidewire has been used, the procedure continues withstep 116 where a region of the deflecting guide catheter is seatedtoward the mitral valve in the apex of the left ventricle as in FIG. 2E.At step 118, the tip of the deflecting guide catheter is advanced up theposterior wall of the left ventricle to a position under the mitralvalve, preferably initially placed in the subvalvular groove in the P2region of the as shown in FIG. 3. The term “annulus” is meant to includeregions at or near the annulus. At step 120 the position of the tip ofthe deflecting guide catheter is confirmed by using an imaging methodsuch as fluoroscopy. If fluoroscopy is used one view maybe sufficientbut it is preferable in most cases to use two views to confirm properplacement of the deflecting guide catheter in the P2 region of themitral valve annulus. P2 is the likely target region for a firstretainer although depending on the geometery of the mitral valve thefirst retainer may be placed in region P1 or region P3. Additionalretainers may need to be placed in the same or other regions.

At step 122 a plication device 400 loaded with one or more retainers isinserted into the deflecting guide catheter and advanced to the tip ofthe deflecting guide catheter. A plication device for use in this methodis described in greater detail herein with respect to FIGS. 12 through14H. At step 124 the rotational orientation of the jaws of the plicationdevice is determined using an imaging method and the jaws are placed inthe correct orientation. The preferable rotational orientation for thejaws of the plication device is such that both tips of the jaws onceopened would represent a “chord” of the arc defined by the mitral valveannulus when pushed into contact with the annulus. Next, at step 126 theplication device is advanced out of the end of the deflecting guidecatheter into position under the annulus of the mitral valve as depictedin FIG. 2E. The orientation and position of the plication device isreconfirmed at step 128 using an imaging method. Again, if fluoroscopyis used as the imaging method, at least one and preferably two views arebe used to confirm orientation and placement of the jaws of theplication device. An injection of a known contrast agent either using aseparate contrast catheter or through the deflecting guide catheter maybe used to help define the line of the annulus as viewed underfluoroscopy. At step 130 a decision is made by the physician whether ornot the jaws of the plication device are properly positioned. If theplication device is not correctly positioned then at step 134 an attemptis made to reposition the jaws of the plication device. At step 136 theposition of the plication device is evaluated again using an imagingmethod as described previously and in more detail below. If theplication device is positioned correctly then step 132 and onward areperformed as discussed below. If the plication device is not positionedproperly after at least one attempt at repositioning at step 134 thenstep 138 results in a determination that the plication device cannotachieve a desired position and the plication device and deflectableguide catheter are withdrawn from the patient at step 150.

If the jaws are properly positioned, a diagnostic clamp or plication isperformed at step 132. As part of the diagnostic clamping (orplication), the jaws of the plication device are opened as depicted inFIG. 2F, the plication device is advanced onto the tissue of the annulusof the mitral valve and the jaws are closed as depicted in FIG. 2G. Thediagnostic plication is evaluated at steps 140, 142 and 144. If thediagnostic plication results in an acceptable change in the mitral valveannulus and/or an acceptable reduction in mitral valve regurgitationthen a retainer is applied using the plication device at step 140 andthe plication device is released as depicted in FIG. 2H. Embodiments ofa retainer that may be applied to the tissue are described in greaterdetail herein with respect to FIG. 15. At step 142, if the diagnosticplication results in an unacceptable change to the mitral valve then theprocedure is abandoned and both the plication device and the deflectableguide catheter are withdrawn from the patient at step 150. At step 144,if the diagnostic plication results in an insufficient or inadequatereduction in mitral valve regurgitation (MR) and/or insufficient orinadequate change in the mitral valve then the diagnostic plication isreleased and an attempt to reposition the jaws of the plication deviceis performed at step 134.

If the change to the mitral valve is acceptable and a retainer has beenapplied, then at step 145 a determination regarding the impact of theplication on the regurgitation of the mitral valve is made using amethod of imaging the flow of blood through the valve such as Dopplerechocardiograpy. At steps 146, 147 and 148 various decisions are maderegarding the procedure and continuation of the procedure. At step 146,if the determination is made that there has been an acceptable totalreduction in mitral valve regurgitation and/or acceptable change in themitral valve then the procedure branches to step 150 with the retrievalof the plication device and the deflecting guide catheter. If the totalchange to mitral valve regurgitation is inadequate or insufficientand/or change to the mitral valve is inadequate or insufficient (step147) then the plication device currently in use is withdrawn if it is asingle retainer device and an additional plication device is insertedand the procedure continues from step 122. If the plication device is amulti-retainer device then the procedure continues from step 124 withoutwithdrawal of the plication device. If the determination regarding theimpact of the plication on mitral valve regurgitation results in afinding of an adverse result at step 148 then the procedure will likelybe abandoned and both the plication device and deflecting guide catheterare removed from the patient at step 150. After removal of the plicationdevice and the deflecting guide catheter, the catheter sheath introduceris removed and the access site is closed at step 152 using knownmethods.

In the above method various imaging modalities may be used to determineproper placement of the plication device under the mitral valve annulus.Fluoroscopy is one real-time imaging modality that is useful,preferably, where images are taken in at least two planes. Radiopaquemarkers placed on the distal end of the plication device and/ordeflecting guide will aid in determining proper placement. Athree-dimensional profile of the plication device can be created usingx-ray images acquired in at least two planar projections in real-time.Alternatively, rotational angiographic imaging may be used.Additionally, registering pre-acquired CT or MRI image data with thefluoroscopic image will provide additional anatomic data to thephysician to aid proper placement of the plication device and retaineror retainer. Similarly, a three-dimensional real-time ultrasound imageacquired in real-time may be registered with the fluoroscopic image.

Another imaging modality useful for this purpose is intracardiacechocardiography (ICE) used to produce an ICE image. The ICE image maybe produced by an ICE catheter placed inside one of the chambers of theheart such as the right ventricle, left ventricle, left atrium or theright atrium. Alternatively, the ICE catheter could be placed inside onof the great vessels of the heart of the patient. The ICE catheter mayalso be placed on the epicardial or pericardial sack surfaces of theheart via a minimally invasive approach such as a sub-xiphoid approach.

No matter the modality used, the images of the mitral valve should betaken synchronized to the cardiac cycle.

Various imaging modalities are also useful in determining whether theplication achieves the desired impact on the function of the mitralvalve in real-time or near real-time prior to applying the retainer tothe plication. Real-time means that the latency period is acceptable toperform the procedure and is preferably no more than 500 milliseconds.Color Doppler ultrasound imaging may be used for such a purpose with orwithout an ultrasound contrast agent being administered to the patient.Alternatively, x-ray fluoroscopy could be used in determining the impactof a plication on mitral valve regurgitation by using an x-ray contrastbolus injection into one of the chambers of the heart, preferably theleft ventricle. Bi-planar angiographic imaging or intra-chamber opticalimaging may also be used. If intra-chamber optical imaging is used it ispreferable that the deflecting guide catheter further comprise anoptical imaging system particularly one that operates in infraredwavelengths.

Determining a location for the first tissue plication may be based on anoptimization plan generated using a three-dimensional functionalnumerical simulation based on imaging data generated by one or more ofthe aforementioned imaging method. For example, by analyzing thedistribution of annular tissue relative to the location of the primaryregurgitant flow through the valve, a primary target for initialplication therapy may be determined. It may be desirable to place theplication at the location of greatest distortion of the annulus due tothe pathology of the patient's heart. The generation of the optimizationplan may be performed prior to step of inserting the crossing catheter.The generation of the optimization plan may be performed after the stepof applying a retainer to the first tissue plication in order todetermine the preferred location for subsequent plication or plications.

Alternatively, the plications could be made on the atrial surface if atransseptal approach is used. This can be accomplished by accessing theright atrium using SVC or IVC venous approaches. Then access the leftatrium is accomplished using a standard transseptal puncture/access kitsuch as a Brockenbrough transseptal needle kit. The deflecting guidecatheter would then be introduced through the puncture and deflectedsuch that the tip pointed towards the annulus of the mitral valve. Thesubsequent steps and devices for a plication annuloplasty procedurewould then be the substantially the same as set forth above except thatthe approach is from the atrial side of the mitral valve rather than theunderside.

The above method is implemented using a multi-component systemcomprising a crossing catheter 200, a deflecting guide catheter 300, anda plication device 400 containing at least one plication retainer 500.FIG. 4 is a perspective view of a crossing catheter 200 for use in theprocedure described in the present application. Crossing catheter 200 iscomprised of a body portion 210 having a proximal end 210 a and a distalend 210 b. Connected to proximal end 210 a are a female luer lock 216and a Tuohy-Borst hemostasis valve 214. At the distal end 210 b portionis attached which is preferably a pigtail 218 or has a “J” configuration(not shown). Pigtail 218 is approximately 2.0 centimeters or less indiameter. In FIG. 4 pigtail 218 is attached to body portion 210 at asplice location that is approximately 4 centimeters from the distal endof the device. Pigtail 218 is attached to body portion 210 using heatbonding as the body portion 210 and pigtail 218 re made from the same orsimilar material. Pigtail 218 is comprised of a polymer, preferably,Pebax® polyether block amide having a durometer of approximately 55 D ifcomprised of one layer or two layers having durometers of approximately40 D in the outer layer and 55 D in the inner layer. Body portion 210may be comprised of one layer having a durometer between 55 D and 72 Dor may have two layers. If two layers are used the preferred durometersare 70 D for the outside and 63 D for the inside. The total length ofthe body portion and pigtail together is approximately 149 centimetersand should extend beyond the deflecting guide catheter when fullyinserted into the deflecting guide catheter thus the length of thecrossing catheter may vary depending on the length of the deflectingguide catheter used. The location at which the pigtail may be attachedto the body portion may also vary from 3 centimeters to approximately44.5 centimeters from the distal tip of the crossing catheter 200. Thecrossing catheter may also be comprised of one material from the bodyportion through the pigtail. In such a case the use of an outer materialwith a durometer of 55 D and an inner material with a durometer of 40 Dis preferred. A flat wire braid 212 of flat wires of approximately0.001″ by 0.003″ may be embedded in the polymer comprising the proximalportion of body portion 210 in order to provide extra stiffness andtorqueability. An inner layer 211 of PTFE provides a lubricious innercoating and a separation between the polymer and the inner lumen. Thestiffness of the pigtail portion of the crossing catheter is chosen sothat a standard guidewire such as the Cordis Emerald 0.035″ guidewirewill open up the pigtail yet will return to the pigtail shape whenretracted. Such a guidewire is placed in the guidewire lumen defined bythe inner layer 211 of the crossing catheter and should extend throughthe entire length of the crossing catheter.

Crossing catheter 200 may be used with or without a guidewire asdescribed above and is preferably used in conjunction with thedeflecting guide catheter depicted in FIGS. 6 through 10A-C. Deflectingguide catheter 300 is comprised of a handle 310 and a body portion 350.FIG. 7A is an exploded view of an embodiment of the handle 310 depictingthe internal components of the handle and FIG. 7B is a perspective viewof the internal components of handle 310 as assembled. Handle 310 iscomprised of upper handle shell 312 and lower handle shell 314 which aremade of a durable moldable polymeric material such as polycarbonate orother similar material and are designed to mate with one another in asnap fit arrangement. At the proximal end of handle 310 is a hemostasisvalve 316 which is adapted to fit onto the proximal handle tip 318.Hemostasis valve 316 may be of any known design for such a valve such asa tuohy-borst type valve. Proximal actuator assembly 324 is comprised ofa thumb actuator 324 a that is adapted to be inserted through slot 313in the upper handle shell 312. Optionally, a two-piece construction witha thumb cap 325 may be used to facilitate assembly if slot 313 isnarrow. The thumb actuator 324 a and optional thumb 325 cap are used tocause forward motion in the proximal direction of puller wire 327 a.Such motion is retained as the prong or prongs 324 e biased by spring324 d around pivot point axel pin 324 c engages the teeth 322 a inproximal rack 322. Such proximal motion of the proximal actuatorassembly 324 and the associated puller wire 327 a causes the deflectionof the distal end of the deflecting guide catheter 300. If the userdesires to have distal motion of the proximal actuator assembly 324 thenthe user pushers release trigger 324 b which counters the bias of spring324 d thereby releasing prong or prongs 324 e from engagement with theteeth 322 a of the proximal rack 322. Alternatively, rather than havinga rack of teeth the prong may engage a tooth (or protrusion) orindentation in the rack or bottom of the handle which would provide alock at a certain point in the motion of the actuator assembly ratherthan an adjustable position as would be the case with the rack of teeth.This alternate design can be used for either or both of the actuatorassemblies. Proximal hypotube 331 a provides a passageway for pullerwire 327 a and prevents kinking of the wire. Distal hypotube 331 b isdesigned to telescope inside hypotube 331 a. At the end of puller wire327 a are fixedly attached crimp tube 334 a and a floating crimp tubestop 334 b that prevents the crimp tube from being embedded in theproximal end of the actuator assembly. The user may then move theactuator assembly distally thereby changing the deflection of the distalend of the deflecting guide catheter. Movement of the actuator assemblymay be made by the physician using something other than his or her thumband the terms “thumb actuator” and “thumb cap” are not meant to belimiting.

Handle 310 further comprises a distal actuator assembly 328 having asimilar thumb actuator 328 a, release trigger 324 b, axel pin 324 c,spring 328 d and prong 328 e. Optional thumb cap 329 is affixed overthumb actuator 328 a. The distal actuator assembly 328 is connected to asecond pullerwire 327 b (shown in FIG. 11) that enables the user tocause deflection of the distal end of the deflecting guide catheter. Ina preferred embodiment the first and second puller wires are attached(through known methods and means such as welding, brazing or adhesives)to anchor bands 385 a and 385 b that are embedded in the distal region360 of the body portion 350 of the deflecting guide. The puller wiresand their respective anchor band connection points may also be arrangedso that they are not next to one another (in an axial manner) but sothat each provides motion of the distal end in another plane or in theother direction within the same plane. Also, the second puller wire andactuator are not necessary if it is only necessary to provide one typeof movement in the deflecting guide catheter. Correspondingly, ifgreater than two types of deflection are required, additional thumbactuator assemblies coupled to puller wires and anchor bands may beadded in a similar manner to the catheter. The second distal actuatorassembly has the same components as functions in the same manner as theproximal actuator assembly. The primary difference is that the distalactuator assembly 328 requires a passageway for passage of the firstpuller wire 327 a through the distal assembly which passage is aided byhypotube 331 b. The second puller wire 327 b ends at the distal end witha similar crimp tube 335 a and crimp tube stop 335 b. Nose cone 330provides a transition between the handle shell 312/314 and the proximalregion 390 of the body portion 350. Actuator assemblies 324 and 328 andracks 322 and 326 are comprised of a polymeric material such aspolycarbonate. Such assemblies could be made of machined or moldedmetal, such as aluminum, although that would result in a higher cost andweight device. Racks 322 and 326 with teeth 322 a and 326 a may beseparate components or may preferably be molded into the lower handleshell 314 as depicted in the alternative embodiment shown in FIG. 11.Handle insert 338 is used as a divider between the two racks 322 and 326and provides a support for proximal hypotube 331 a. Puller wires 327 aand 327 b are preferably high tensile strength 304 stainless steel (e.g.tensile strength greater than 300 ksi) but may also be made of otherhigh strength materials such as MP35N, other stainless steel, or wovenfibers such as Kevlar or Vectran.

Puller wires 327 a and 327 b are preferably a single, solid core hightensile strength 304 stainless steel wire (e.g. tensile strength greaterthan 300 ksi) of approximately 0.008″ in diameter but may also be madeof other high strength materials such as MP35N, other stainless steel,or woven fibers such as Kevlar or Vectran. At the distal end of eachpuller wire is an anchor band 385 a or 385 b that is embedded in thewall of the catheter body at the point of anchoring. Changing thelocation of the anchor band along the axial length of the catheter bodywill change the deflection profile of the deflectable guide catheter.

Body portion 350 of deflecting guide catheter 300 is depicted in FIG. 8and FIGS. 9A and 9B. Body portion is separated into four regions: distalregion 360, intermediate distal region 370, main intermediate region 380and proximal region 390. Distal region 360 at the distal end isapproximately 3.5 centimeters in length and is made of a polymericmaterial such as Pebax with a durometer of between 25 D and 40 D andpreferably 35 D. A radiopaque material such as bismuth subcarbonate isadded to the material in distal region 360 to enable the distal region360 of the deflecting guide catheter 300 appear in fluoroscopy and otherimaging procedures. The wall thickness in the distal region 360 isbetween approximately 0.012 and 0.014 inches. The anchor band 385 a forthe first puller wire is embedded near the distal end of distal region360 and the anchor band 385 b for the second puller wire is embeddednear the proximal end of distal region 360 or at the distal end ofregion 370. This arrangement may also be reversed so that the anchorband for the first puller wire is embedded near the proximal end of thedistal region and the anchor band for the second puller wire is embeddednear the distal end of the distal region. It is also possible to placethe anchor bands next to one another rather than longitudinallyseparated as depicted in the embodiment shown. The anchor bands arepreferably tubular metal bands preferably placed between the lubriciousliner 365 and the braid 375 although it could be placed above the braidin an alternative embodiment. Each anchor band is made of 304 stainlesssteel and each puller wire is attached to its respective anchor bandusing welding or other means for joining metal that is known in the art.FIG. 9C depicts an alternative arrangement of the proximal anchor band385 a in which a notch or lumen is placed in the anchor band to allowthe passage of the second puller wire 327 b in braid reinforced pullerwire lumen 395 b through at least a radial portion of the anchor band.Puller wire 327 a is attached to anchor band 385 a. This arrangementenables the catheter to have a more symmetrical and smaller profile atthis point. The internal diameter of distal region 360 as well as theentire body portion is defined by a lubricious liner 365 preferably PTFEthat has an interior diameter of approximately 0.127 inches and isapproximately 0.002 inches thick. The outer diameter of distal region360 is approximately 0.172 inches between the anchor bands andapproximately 0.176 inches at the location of the distal band. A braid375 of wires having a diameter between 0.0025 and 0.003 inches in eithera 1 over 1, 1 over 2 under 2 or 2 over 2 pattern is embedded in thepolymeric wall of the catheter from the proximal region 390 to thedistal region 360. At the distal end of the distal region 360 ofdeflecting guide 300 is an extruded atraumatic tip 362 comprised ofapproximately 33.5% 25 D Pebax, approximately 6.4% 55 D Pebax andapproximately 60% bismuth subcarbonate and having a slight taper towardits distal end. The atraumatic tip is optional although preferred inorder to avoid tissue damage during insertion into the vessels of thepatient. In an alternative embodiment, the distal region 360 iscomprised of a polymeric material having a higher durometer than boththe atraumtic tip 362 and the intermediate distal region 370. Thisstiffer distal region between anchor bands 382 a and 385 b will enablethe deflection profile of the deflecting guide catheter to be altered insuch a way as to allow the deflected shape of the catheter to bettermatch the shape of the target anatomy for the device. In addition, analternative embodiment adds an additional region of material between thedistal and intermediate distal regions, which is of a durometerdifferent from that of both adjacent regions. This is also done to alterthe deflected shape of the catheter in a favorable manner and create aregion which either deflects much more or much less (depending if thedurometer is lower or higher than adjacent regions) than the adjacentregions.

Intermediate distal region 370 is comprised of the same type ofpolymeric material but has a higher durometer of between 35 D and 55 Dto provide a stiffer region. Intermediate distal region 370 is betweenapproximately 2.8 and 4.0 centimeters in length and contains the samelubricious liner 365 and wire braid 375 as the distal region. The wallthickness in the intermediate distal region is similarly between 0.012and 0.014 inches and the outer diameter is approximately 0.172 inches.Main intermediate region 380 has a slightly smaller outer diameter at0.166 inches but has the same lubricious liner and braid as the otherregions. The main difference in this region is the higher durometer ofbetween 55 D and 63 D for the polymeric material used in order toprovide increasing stiffness. The main intermediate region isapproximately 20 to 30 centimeters in length, preferably 20 centimeters.Proximal region 390 has a similar composition in that the outer diameteris the same as the immediately prior region. The durometer in thisregion is increased to approximately 72 D providing even greaterstiffness and the length of this region is approximately 73 to 90centimeters, preferably 88 centimeters. The lubricious layer 365 andbraid 375 are the same.

From the proximal region 390 through the body portion 350 until theposition of first and second anchor bands 385 a/385 b run two braidreinforced tubes 395 a/395 b of approximately 0.0088 inches in internaldiameter which house the first and second puller wires respectively.Various modifications can be made to the deflecting guide catheter ifdifferent characteristics are desired. One puller wire, anchor band andreinforced tube could be used instead of two. The braid may be changedto a different size or cross section (such as elliptical) wire and braidtype. The polymeric material of the outer body may be varied as depictedin FIGS. 10A-10C. In FIG. 10A materials having two different durometersare used in an alternating fashion. Material A is used in twocircumferential portions opposite one another while material B is usedin two other opposing circumferential portions. The durometer ofmaterial A may be greater than the durometer of material B or vice versadepending on the deflection characteristics desired. Use of twodifferent durometer materials in such a way provides the benefit ofbalancing the ability or ease of the catheters to deflect in aparticular direction with the requirement for lateral stiffness. In FIG.10B two circumferential portions of material A and material B are usedto provide a certain desired deflection characteristic. In FIG. 10C theuse of two different durometer materials is used in conjunction withplacement of the puller wires 327 a and 327 b at different places alongthe circumference of the body portion. In the configuration in FIG. 10Cthe distal end of the deflecting guide catheter would deflect in twodifferent planes substantially perpendicular to one another. One shouldnote that it is not required to use two different materials or durometertypes around the circumference of the outer body in order to getdifferent planes of deflection. The planes of deflection are primarilydetermined by the relative placement of the puller wire lumens.

The deflecting guide catheter may further comprise a magnetic basedlocation sensor such as those manufactured by Biosense Webster forsensing the location and orientation (six degrees of freedom) of thedistal end of the deflecting guide catheter and for providing locationinformation that may be registered with other preaquired or real-timeimages or otherwise used to depict the location of the distal end of thedeflecting guide catheter on a real-time display map of the heart.Systems such as the Carto® system produced by Biosense Webster would beuseful for this purpose.

FIG. 12 is an elevational view of a plication device 400 for use in themethod of treating mitral valve regurgitation in accordance with thepresent invention. Plication device 400 is comprised of a handleassembly 410 and a distal assembly 450 having an elongate shaft 452 atthe distal end of which are attached a plication assembly with an endeffector 520. FIG. 13 is an elevational view of the internal componentsof the handle assembly 410. Handle assembly 410 is comprised of twopolycarbonate shell portions right handle shell 412 and left handleshell 414 that are adapted to house the internal components of thehandle assembly. Internal to handle assembly 410 reside crank assembly420 for advancing a retainer stored in the distal portion of theelongate shaft 452. The firing assembly 420 is comprised of counter gear421, drive gear assembly 422, idle gear 423, and crown gear 424. Firingassembly 420 is coupled to the firing knob 430, shown in FIG. 12, whichis rotatably coupled to left handle shell 414. While not shown, a secondfiring knob can be disposed on the opposed side of the handle assembly410 to allow a user to selectively rotate either knob. Either firingknob further comprises a anti-backup leaf spring (not shown) thatprevents the knob from turning in the reverse direction and a triggerlockout spring (not shown) that prevents the knob from turning until thetrigger is fully closed or engaged. Continuing to refer to FIG. 13, thegears 421, 422, 423 and 424 of firing assembly 420 are configured torotate in response to rotation of the firing knob 430. The gearscommunicate with one another to cause corresponding rotation of pinionassembly 437 and drive shaft 436. Drive shaft 436 is mated to a proximalend of firing control wire 490. End cap 460 has a plurality of ridgesdispersed around it circumference to aid the grip of the user.

In FIG. 13, the trigger 416 is pivotally mounted within the handleassembly 410 by a pivot pin 417, and includes a distal portion having athumb grip formed therein and a proximal extension arm 418. The trigger416 also includes a latch 419 a that is adapted to be received in thelatch receiver 419 b in the handle assembly to lock the trigger into aclosed position. The extension arm 418 is coupled to a shuttle assembly440 that moves between proximal and distal positions within the housingassembly 410. The shuttle assembly 440 can have various configurationsand it can include various features, such as an overload mechanism. Theparticular configuration of the shuttle assembly 440 is described inmore detail in U.S. Patent Publication No. 2005/0277954 hereinincorporated by reference. Some of the internal parts of the shuttleassembly 440 including spring pin 446, force limiting spring 442, springcaps 444 a and 444 b are shown in FIGS. 14A and 14B. As shown in FIG.13, the shuttle assembly 440 is coupled to a proximal portion ofend-effector control wire 510, which extends through the elongate shaft452. The distal end of the end effector control wire 510 mates(preferably by welding) to wire connector 542, which is shown in FIG.14D The wire connector 542 is positioned as shown in FIG. 14G proximalto the end effector 520, i.e., the clevis 522 and jaws 524 a and 524 b.Wire connector 542 is also welded to two parallel pull wires 544 a and544 b that run from wire connector 542 through nut 550 and terminate inholes at the proximal end of jaws 524 a and 524 b respectively. Thus,wire connector 542 splits the force of end effector control wire 510into two forces for controlling the opening and closing of the jaws.Other arrangements are possible if, for example, it would be desired tohave one fixed jaw and one movable jaw rather than two movable jaws. Itis also possible to have some passive articulation of the distal jaws524 a and 524 b by having the pull wires 544 a and 544 b pass throughwire connector 542 as depicted in FIG. 14H and placing a plurality offerrules 549 in each pull wire 544 a and 544 b, one each proximally anddistally of the wire connector 542 proximal end of each wire so thatthey may translate through the wire connector thereby providingflexibility at the distal tip of the device for improved maneuverabilitythrough tortuous anatomical pathways. Distal jaws 524 a and 524 b rotatearound pivot point rivots 523 a and 523 b respectively.

The firing control wire 490 extends through the elongate shaft 452 andthrough a bore formed in the wire connector 542 and is threadably matedto a threaded bore in nut 550. The distal end of the firing control wire490 extends into a retainer pusher 554 set in a retainer pusher sleeve556, both of which are shown in FIG. 14E and which is described in moredetail in US. Publication No. 2005/0277954. In general, rotation of thefiring knob 430 is effective to rotate the firing control wire 490.Since the firing control wire 490 is threadably mated to the nut 550,which is fixed between the proximal and distal portions of the elongateshaft 452, the threaded bore in nut 550 will cause the firing controlwire 490 to move distally through the elongate shaft 452, therebyadvancing the retainer pusher 554 in a distal direction. The retainerpusher 554 is positioned proximal to one or more retainers 500 storedwithin a garage 532 in the distal portion of the elongate shaft 452, andthus distal movement of the pusher 554 will advance the retainers 550through the shaft 452 to position the distal most retainer within thejaws 524 a and 524 b of the end effector 520. A person skilled in theart will appreciate that a variety of other techniques can be used toadvance a plurality of retainers through the elongate shaft and toposition a retainer within the jaws.

At the proximal end of the elongate shaft 452 is the coil connector 512which is made of a metal, preferably brass, and is used as a means forconnecting the proximal portion 452 a of elongate shaft 452 to thehandle assembly. Dual lumen inner sheath 560 has lumens for end-effectorcontrol wire 510 and firing control wire 490. Filler tube connector 562is used to connect the coil connector 512 to the elongate shaft 452 andis glued to coil connector 512 and elongate shaft 452 using an adhesiveglue such as cyanoacrylate. Elongate shaft 452 is broken into proximalshaft section 452 a and distal shaft section 452 b. Proximal shaftsection 452 a is preferably nitinol and has a dovetail laser pattern.Distal shaft section 452 b is preferably stainless steel and has asimilar dovetail pattern cut through the wall of the shaft. Otherpatterns could also be used such as a helical cut as shown in FIG. 16A.FIG. 16B depicts another variation of the plication device where theproximal shaft section is similar to that above but the nut is placedsignificantly more distally and the stainless steel distal shaft sectionwith a dovetail pattern is replaced with a helical cut creating a ribboncoil. FIG. 16C depicts the placement of the nut and the dovetailpatterns of the proximal and distal shaft portions discussed withrespect to FIGS. 14A-F above. FIG. 16D depicts the passivelyarticulating jaws of the alternative embodiment discussed above.

A preferred retainer 500 for us in the present system and method isshown in FIG. 15. Retainer 500 is comprised of stainless steel or otherbiocompatible material such as MP35N, platinum, nitinol and cobaltchromium or alloys thereof. The helical retainer may also be made of aor polymeric material such as one made of poly lactic acid

(PLA) and/or poly glycolic acid (PGA). The retainer is comprised of ametal alloy with the preferred embodiment containing at least a trace ofan element having an atomic number greater than 53 such as platinum toenhance visibility of the retainer under fluoroscopy. Additionally, asufficient wall thickness should be chosen to ensure visibility underfluoro. The shape of the tip of the distal jaws of the plication devicealso have an alignment feature when viewed under fluoro that allows theviewer to determine which of 2 orientations (0/180 or 90/270) the jawsare in. In a 0/180 orientation the tip of the jaws form a circle asdepicted in FIG. 14F. In a 90/270 orientation the tip of the jaws form aminus as depicted in FIG. 14B. The retainer 500 is preferably “C” shapedwith elongated legs which may vary in length depending on the depth oftissue to be penetrated and the number of retainers that are desired tobe housed within the garage of the plication device. The tips 501 aredesigned to be folded by the distal tips of the jaws of the end effectorduring the process of advancement to prevent the retainer from backingout or being pulled out of the plicated tissue. The retainer could becoated with one or more pharmacologically active agents such as heparinfor the purpose of reducing thrombotic potential.

The plication device may further comprise a magnetic based locationsensor such as those manufactured by Biosense Webster for sensing thelocation and orientation (six degrees of freedom, x, y, z, roll (Xrot),pitch (Yrot) and yaw (Zrot)) of the distal end of the deflecting guidecatheter and for providing location information that may be registeredwith other preaquired or real-time images or otherwise used to depictthe location of the distal end of the deflecting guide catheter on areal-time display map of the heart. Systems such as the Carto® systemproduced by Biosense Webster would be useful for this purpose. Theincorporation of the magnetic based location sensor near the distal tipof the plication device, preferably approximately 28 mm proximal fromthe distal tip, enables precise orientation of the jaws in order tofacilitate placement of the jaws and plication of the tissue. Themagnetic location sensors would be placed proximal the distal end of thejaws of the plication device due to shielding if such sensors wereplaced in the jaws themselves. Location information is then transmittedthrough electrical conductors to circuitry in the handle of theplication device which is electrically connected to a Carto® mappingsystem. The Carto® mapping system will then use the location informationfrom the magnetic location sensors in order to extrapolate the locationand layout of the distal end of the plication device. A sensor shouldalso be placed in the handle of the plication device that would providea signal to the Carto® system indicative of the open/closed position ofthe jaws. With this information the Carto® system will be able todisplay a real-time image of the heart and the location of the distalend of the plication device within the left ventricle, etc.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces, and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning and/or replacement, and reassembly. Use of such techniques, andthe resulting reconditioned device, are all within the scope of thepresent application.

The preceding description has been presented with reference to presentlypreferred embodiments of the invention. Workers skilled in the art andtechnology to which this invention pertains will appreciate thatalterations and changes in the described structure may be practicedwithout meaningfully departing from the principal, spirit and scope ofthis invention.

Accordingly, the foregoing description should not be read as pertainingonly to the precise structures described and illustrated in theaccompanying drawings, but rather should be read consistent with and assupport to the following claims which are to have their fullest and fairscope.

1. A deflecting guide catheter for guiding a medical device through alumen of a patient during a medical procedure comprising: an elongatedtubular body portion having a lumen and a distal end and proximal end;an anchor band near the distal end of the elongated tubular bodyportion; a handle assembly attached to the proximal end of the elongatedtubular body portion wherein the handle assembly comprises an actuatorassembly; a puller wire connected from the actuator assembly to theanchor band wherein movement of the actuator assembly in a proximaldirection causes proximal movement of the puller wire and deflection ofthe distal end of the deflecting guide catheter; and a second pullerwire attached to a second anchor band near the distal end of thedeflecting guide catheter for deflecting the distal end of thedeflecting guide catheter in response to proximal movement of the secondpuller wire caused by proximal movement of a second actuator assemblyattached to the proximal end of the second puller wire.
 2. Thedeflecting guide catheter of claim 1 wherein at least one prong on theactuator assembly engages at least one tooth located in the handleassembly in order to retain movement of the puller wire in the proximaldirection.
 3. The deflecting guide catheter of claim 2 wherein theactuator assembly further comprises at least one pivot point axel pinand a spring that bias the prong of the actuator assembly against thetooth.
 4. The deflecting guide catheter of claim 3 wherein the actuatorassembly further comprises a release trigger for removing the springbias and permitting distal movement of the actuator assembly therebyreducing the deflection of the distal end of the deflecting guidecatheter.
 5. The deflecting guide catheter of claim 1 wherein the anchorband is embedded in the wall of the elongated tubular portion.
 6. Thedeflecting guide catheter of claim 1 wherein the handle assembly furthercomprises a hemostasis valve at the proximal end for passage of themedical device through the handle assembly and into the lumen of theelongated tubular portion.
 7. The deflecting guide catheter of claim 1wherein the puller wire is comprised of high tensile strength material.8. The deflecting guide catheter of claim 7 wherein the tensile strengthof the puller wire is greater than 300 ksi.
 9. The deflecting guidecatheter of claim 7 wherein the puller wire is comprised of high tensilestrength woven fibers.
 10. The deflecting guide catheter of claim 7wherein the puller wire is comprised of MP35N.
 11. The deflecting guidecatheter of claim 1 wherein the puller wire is comprised of stainlesssteel.
 12. The deflecting guide catheter of claim 1 wherein the elongatetubular body portion comprises a distal region, an intermediate distalregion, a main intermediate region and a proximal region.
 13. Thedeflecting guide catheter of claim 12 wherein the distal region isapproximately a few centimeters in length and is made of a polymericmaterial blended with a radiopaque material.
 14. The deflecting guidecatheter of claim 13 wherein the radiopaque material is bismuthsubcarbonate.
 15. The deflecting guide catheter of claim 12 wherein afirst anchor band is embedded near the distal end of distal region and asecond anchor band is embedded near the proximal end of distal region.16. The deflecting guide catheter of claim 12 wherein the durometer ofthe polymeric material of the distal region is between approximately 25D and 40 D.
 17. The deflecting guide catheter of claim 16 wherein thedurometer is 35 D.
 18. The deflecting guide catheter of claim 12 whereinthe distal region comprises an extruded atraumatic tip at its distal endhaving a slight taper toward its distal end.
 19. The deflecting guide ofclaim 18 wherein the extruded atraumatic tip comprises a polymericmaterial blended with a radiopaque material.
 20. The deflecting guidecatheter of claim 12 wherein the intermediate distal region is comprisedof a polymeric material having a higher durometer than the distalregion.
 21. The deflecting guide catheter of claim 20 wherein thepolymeric material of the intermediate distal region has a durometerbetween approximately 35 D and 55 D.
 22. The deflecting guide catheterof claim 12 wherein the main intermediate region is comprised of apolymeric material having a higher durometer than the intermediatedistal region.
 23. The deflecting guide catheter of claim 22 wherein thepolymeric material of the main intermediate region has a durometerbetween approximately 55 D and 63 D.
 24. The deflecting guide catheterof claim 22 wherein the main intermediate region is approximately 20 to30 centimeters in length.
 25. The deflecting guide catheter of claim 12wherein the proximal region is comprised of a polymeric material havinga higher durometer that the main intermediate region.
 26. The deflectingguide catheter of claim 25 wherein the durometer of the proximal regionis approximately 72 D.
 27. The deflecting guide catheter of claim 25wherein the proximal region is approximately 73 to 90 centimeters inlength.
 28. The deflecting guide catheter of claim 12 wherein thestiffness of the material comprising the distal region is greater thanthe stiffness of the intermediate distal region.
 29. The deflectingguide catheter of claim 1 wherein the elongated tubular body portion iscomprised of regions of increasing stiffness from the distal end to theproximal end.
 30. The deflecting guide catheter of claim 1 wherein theelongate tubular body portion is comprised of a lubricious liner, atubular wire braid and a polymeric material.
 31. The deflecting guidecatheter of claim 30 wherein anchor bands are embedded in the polymericmaterial between the lubricious liner and tubular wire braid.
 32. Thedeflecting guide catheter of claim 1 wherein the first anchor band andthe second anchor band are spaced apart longitudinally near the distalend of the deflecting guide catheter.
 33. The deflecting guide catheterof claim 1 wherein at least one prong on the second actuator assemblyengages at least one tooth mounted in the handle assembly in order toretain movement of the second puller wire in the proximal direction. 34.The deflecting guide catheter of claim 32 wherein the second actuatorassembly further comprises at least one pivot point axel pin and aspring that bias the prong of the actuator assembly against the tooth.35. The deflecting guide catheter of claim 34 wherein the secondactuator assembly further comprises a release trigger for removing thespring bias and permitting distal movement of the actuator assemblythereby reducing the deflection of the distal end of the deflectingguide catheter.
 36. The deflecting guide catheter of claim 35 whereinthe second actuator assembly further comprises a lumen through which thefirst puller wire passes.
 37. The deflecting guide catheter of claim 1wherein the proximal movement of the second puller wire causes thedeflecting guide catheter to deflect in a different plane from thedeflection caused by proximal movement of the first puller wire.
 38. Thedeflecting guide of claim 36 wherein the second puller wire attaches tothe second anchor band at a position that is spaced radially apart fromthe position at which the first puller wire attaches to the first anchorband.
 39. The deflecting guide of claim 1 wherein the second puller wireattaches to a position on the second anchor band that is minimallyspaced apart radially from the point of attachment of the first pullerwire to the first anchor band thereby causing the distal tip of thecatheter to deflect in substantially the same plane when the first andsecond puller wires are moved in the proximal direction.
 40. Thedeflecting guide of claim 1 wherein the first anchor band has a notch orlumen therein for passage of the second anchor wire therethrough. 41.The deflecting guide catheter of claim 1 wherein the first actuatingassembly comprises a first hypotube attached to the distal end and thesecond actuating assembly comprises a second hypotube attached to theproximal end which is adapted to be telescopically received within thefirst hypotube said first and second hypotubes are adapted to receivethe first puller wire.
 42. The deflecting guide of claim 1 furthercomprising at least one magnetic location sensor mounted near the distalend for determining the location of the distal end of the deflectingguide catheter in conjunction with a magnetic location sensing system.43. The deflecting guide catheter of claim 1 wherein the elongatedtubular body portion is comprised of polymeric materials having twodifferent durometers used in a radially alternating pattern with a firstmaterial used in two circumferential portions opposite one another and asecond material used in two other opposing circumferential portions. 44.The deflecting guide catheter of claim 43 wherein the durometer of thefirst material is greater than the durometer of the second material. 45.The deflecting guide catheter of claim 44 wherein the first puller wireis attached to the first anchor band at a position in the first materialand the second puller wire is attached to a second anchor band at aposition in the second material.
 46. The deflecting guide catheter ofclaim 1 wherein the elongated tubular body further comprises a pullerwire lumen in which the puller wire resides.
 47. The deflecting guidecatheter of claim 46 wherein the puller wire lumen is braid reinforced.